My3D® Personalized Pelvic Reconstruction
My3D Personalized Pelvic Reconstruction combines a patient-matched pelvic implant with screws and hip-joint components. Imaging, diagnosis and the planned surgical approach guide a design…
My3D Personalized Pelvic Reconstruction combines a patient-matched pelvic implant with screws and hip-joint components. Imaging, diagnosis and the planned surgical approach guide a design developed with the surgeon.
The additively manufactured pelvic implant attaches to remaining pelvic anatomy with compatible bone screws to create a prosthetic acetabulum. The pelvic implant uses cementless fixation, while the compatible acetabular cup is cemented into the reconstruction.
Listed Item
Conical Screw Extractor, 4.5 -7.0MM Screws, AO Connection
Joint and Instrument Components
The reconstructed joint also uses a dual-mobility POLARCUP insert and femoral components. Patient-specific resection instruments may guide bone preparation, and reusable tools are supplied in nonsterile surgical trays. A listed screw extractor belongs to this instrumentation range; implants and patient-specific resection instruments are single-use.
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (3), Zhejiang (2). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Xian Airfoil Technology Co., Ltd. | Xian | Shaanxi | Contract manufacturer | 8 |
| Lincotek (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 7 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Showing 12 of 14. All 14 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Record
| Listed by | Onkos Surgical, Inc., United States |
|---|---|
| FDA product code | LPH |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3358 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K212815 |
| Record published | 2025-09-22 |
| Record revised | 2025-02-06 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DV-MOD35-04N | In distribution | |
| CS-65065-04M | In distribution | |
| DR-43050-04N | In distribution | |
| PN-32089-04N | In distribution | |
| DR-432NS-04N | In distribution | |
| LS-50028-04M | In distribution | |
| AM-C3DMD-04N | In distribution | |
| DV-RGD35-04N | In distribution | |
| CS-65100-04M | In distribution | |
| DV-RGDMD-04N | In distribution | |
| EX-35065-04N | In distribution | |
| DG-45120-04N | In distribution | |
| LS-50038-04M | In distribution | |
| LS-50048-04M | In distribution | |
| CS-65075-04M | In distribution | |
| CS-65070-04M | In distribution | |
| LS-50042-04M | In distribution | |
| CS-65095-04M | In distribution | |
| CS-65020-04M | In distribution | |
| TP-65025-04N | In distribution | |
| LS-50060-04M | In distribution | |
| DR-4350N-04N | In distribution | |
| LS-50022-04M | In distribution | |
| CS-65120-04M | In distribution | |
| DR-4325N-04N | In distribution | |
| LS-50065-04M | In distribution | |
| PV-TRAY1-04T | In distribution | |
| PV-GUIDE-04N | In distribution | |
| LS-50012-04M | In distribution | |
| CS-65105-04M | In distribution | |
| CS-65110-04M | In distribution | |
| LS-50044-04M | In distribution | |
| PV-65TRY-04T | In distribution | |
| LS-50055-04M | In distribution | |
| DV-35000-04N | In distribution | |
| DG-CS020-04N | In distribution | |
| HD-10000-04N | In distribution | |
| CS-65045-04M | In distribution | |
| PV-TRAY2-04T | In distribution | |
| LS-50016-04M | In distribution | |
| SF-65000-04N | In distribution | |
| LS-50070-04M | In distribution | |
| LS-50036-04M | In distribution | |
| LS-50050-04M | In distribution | |
| CS-65085-04M | In distribution | |
| DG-SP036-04N | In distribution | |
| CS-65040-04M | In distribution | |
| HD-38016-04N | In distribution | |
| LS-50018-04M | In distribution | |
| LS-50032-04M | In distribution | |
| CS-65010-04M | In distribution | |
| PV-TRYLD-04T | In distribution | |
| DV-FLXMD-04N | In distribution | |
| LS-50040-04M | In distribution | |
| CS-65055-04M | In distribution | |
| LS-50030-04M | In distribution | |
| LS-50090-04M | In distribution | |
| DG-LS040-04N | In distribution | |
| TP-65180-04N | In distribution | |
| LS-50075-04M | In distribution | |
| LS-50045-04M | In distribution | |
| LS-50095-04M | In distribution | |
| CS-65050-04M | In distribution | |
| TP-65050-04N | In distribution | |
| LS-50015-04M | In distribution | |
| LS-50020-04M | In distribution | |
| HD-BP332-04N | In distribution | |
| LS-50014-04M | In distribution | |
| CS-65115-04M | In distribution | |
| AM-M3DMD-04N | In distribution | |
| LS-50035-04M | In distribution | |
| CS-65030-04M | In distribution | |
| CS-65015-04M | In distribution | |
| CS-65035-04M | In distribution | |
| CS-65025-04M | In distribution | |
| CS-65060-04M | In distribution | |
| DG-65120-04N | In distribution | |
| LS-50024-04M | In distribution | |
| LS-50080-04M | In distribution | |
| DG-LS100-04N | In distribution | |
| DR-43025-04N | In distribution | |
| HD-35TRQ-04N | In distribution | |
| PV-ACREC-04M | In distribution | |
| LS-50085-04M | In distribution | |
| LS-50025-04M | In distribution | |
| LS-50046-04M | In distribution | |
| PV-APRCN-04M | In distribution | |
| CS-65090-04M | In distribution | |
| HD-THDAO-04N | In distribution | |
| DR-43200-04N | In distribution | |
| LS-50026-04M | In distribution | |
| CS-65080-04M | In distribution | |
| LS-50010-04M | In distribution | |
| LS-50034-04M | In distribution | |
| AP-38016-04M | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Initia Total Hip System | Kyocera Medical Technologies, Inc. | 1,000 |
| DJO Surgical | Encore Medical, L.P. | 624 |
| Pinnacle | Depuy Orthopaedics, Inc. | 613 |
| Trilogy® Longevity® | Zimmer, Inc. | 564 |
| Instrument | Howmedica Osteonics Corp | 369 |
| InSitu Hip System | Nextstep Arthropedix | 368 |
| Trilogy® | Zimmer, Inc. | 359 |
| Kyocera Medical Technologies, Inc. | Kyocera Medical Technologies, Inc. | 298 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Zimmer, Inc. | 286 |
| Bencox Hip System | Corentec Co., Ltd. | 286 |
| OrthoMedFlex | Orthomedflex LLC | 257 |
| Sterizo Total Hip System | CPM Medical Consultants, LLC. | 240 |
Showing 12 of 792. All products under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K223348 | 2023-01-30 |
| K212815 | 2022-07-06 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P880025 | 1991-12-04 | AML(R) POROCOAT(R) ACETABULAR CUP PROSTHESIS | Depuy Intl., Ltd. |
| P880076 | 1991-06-17 | WHITESIDE EPS(TM) FEMORAL HIP PROSTHESIS | Dow Corning Wright |
| P850061 | 1991-03-08 | BIAS(R) FIBER METAL TOTAL HIP SYSTEM | Zimmer, Inc. |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.